PharmaRelations / Euro Diagnostica

Director of Corporate Quality

Background Euro Diagnostica manufactures and sells ELISAs and cell-based assays to clinical laboratories, other providers of immunoassays, and pharmaceutical companies. Many of these products are manufactured in accordance with ISO13485/21 CFR part 820 but others are sold as Research Use Only (RUO) products. The Wieslab business unit undertakes testing of clinical samples in accordance with ISO 17025 and pharmaceutical samples in accordance with GLP.
Upprättad
Ansökningsfrist
den 25 augusti 2017
Förväntad start.
den 1 oktober 2017
Antal jobb
1
Anställningsförhållanden
Fast
Antal timmar
Fulltid
Anställning
Fast
Arbetsplats
Sverige > Skåne län > Malmö stad

PharmaRelations is now recruiting a Director of Corporate Quality to Euro Diagnostica. The position is based in Malmö and you will be reporting to the CEO.

The Job

The Director of Corporate Quality Unit has the overall responsibility for the corporate quality systems, and the Quality Assurance (QA) and Regulatory Affairs (RA) personnel that ensure customer satisfaction and compliance with all regulatory requirements and International standards. The Director is part of the Management Team and Management Representative for the Quality Management System. He or she provides input to the CEO on quality status and continuous improvements. The Director manages all Quality Unit personnel and is responsible for their hiring, performance management and professional development. In addition, the Director has oversight of all aspects of quality within the company. The Director must be able to work both strategic and operational.

Essential Functions QA:

  • Ensure compliance with all international standards and requirements for our product types
  • Manage the QMS ensuring effectiveness and continuous improvement
  • Report to management on quality issues, trends and effectiveness
  • Initiate and implement quality improvement activities as appropriate to raise our performance
  • Participate in internal and external quality audits and inspections
  • Educate and train employees in the quality management system
  • Establish and implement metrics (process capability, control charts, Measurement quality) for monitoring quality system effectiveness and to enable managers to make sound product quality decisions
  • Support and participate in design development representing quality assurance and our customers
  • Assist in design, implementation and documentation of procedures for process control, process improvement, testing and inspection.
  • Participate in monitoring of vendor/outsourcing partner performance and establish criteria and rating system for critical vendors to ensure compliance with supplier quality requirements

Essential Functions RA:

  • Ensuring that the Company's products comply with the regulations of the countries in which the products are sold
  • Provide ntelligence to ensure regulatory compliance in all countries, to which the company is exporting, are updated and continuously improving RA QMS
  • Developing and writing clear arguments and explanations for new product registrations and registration renewals
  • Submission of regulatory data including, but not limited to, new registrations, 510(k)s, license renewals etc. to strict deadlines
  • Monitoring and setting timelines for registrations variations and renewal approvals
  • Prepare and update IFUs and SDSs and provide input to labelling
  • Advising relevant staff on regulatory requirements
  • Providing strategic advice to senior management throughout the development of a new product
  • Contribute to development projects for new and existing products including input to product trials and interpreting trial data
  • Ensure correct communication/reporting to authorities and represent RA during inspections/audits
  • Ensure impact assessment and implementation of IVDR.

Key Qualifications

Experience of working with implementation and maintenance of US and EU regulatory requirements for IVD, Medical Devices, GLP or GMP. Relevant degree areas include life, physical, mathematical, applied and medical sciences. In particular, the following subjects may increase your chances:

biochemistry; biology; biomedical science; biotechnology; chemical and physical sciences; chemistry; life sciences; medicine; pharmacology; pharmacy.

Experience with both medical devices (IVD) as well as pharmaceutical products would be an advantage.

Ability to effectively communicate with peers and customers both in writing and verbally, in Swedish and English.

Knowledge and skills

  • Communication Proficiency
  • Decision Making
  • Organizational Skills
  • Problem Solving/Analysis
  • Results Driven
  • Technical Capacity
  • Thoroughness
  • Time Management.

Skicka din ansökan

In this recruitment, Euro Diagnostica collaborates with PharmaRelations. The application process is ongoing, so apply as soon as possible, but no later than August 25th 2017.

If you have any questions about the position, do not hesitate to contact Kim Raabymagle, Country Manager at PharmaRelations; +45 51 19 91 97 or kim.raabymagle@pharmarelations.dk

Apply here





Kontaktinformation
PharmaRelations / Euro Diagnostica

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